Platform Trials Are Neurology’s Best Bet — So Why Is the FDA Still Treating Them Like Experiments?
The Lancet calls MAMS platform trials the fix for neurodegenerative drug failure. With 182 Alzheimer's trials active in 2025,...
Rogaratinib’s 41.7% Response Rate in SDH-Deficient GIST Rewrites the Playbook for Epigenetically Driven Trial Design
A 24-patient Phase 2 trial of rogaratinib hit 41.7% partial response in SDH-deficient GIST—a tumor that imatinib cures just...
Astegolimab’s Split Verdict: What ALIENTO’s Win and ARNASA’s Miss Reveal About COPD Trial Design
Astegolimab cut COPD exacerbations in Phase 2b but missed in Phase 3—a 14.5% gap that exposes critical flaws in...
CDR132L’s Phase 2 Miss: What a Well-Run Negative Trial Reveals About Heart Failure Drug Development
Cardior's CDR132L cleared safety hurdles in phase 2 but missed primary cardiac structure endpoints—a rigorous negative result that reshapes...
SPARK Just Ran 5,400-Patient Oncology Research Autonomously. Your Trial’s Biomarker Strategy Has Not Caught Up.
SPARK agentic AI validated prognostic biomarkers across 5,400 patients and 18 cancer types—here's what that means for trial enrichment...
BIOMEDE Missed Its Primary Endpoint — And Still Changed Pediatric CNS Trial Design Forever
The BIOMEDE Phase 2 trial in DIPG missed OS superiority but exposed a biomarker-survival link that should rewrite how...
Ewing Sarcoma’s EWS::FLI1 Trial Just Showed What Precision Oncology Has Been Promising for a Decade
A Nature Medicine phase 1/2 trial of trabectedin plus low-dose irinotecan targeting EWS::FLI1 in Ewing sarcoma signals a new...
The FDA Just Opened a Door in Anal Cancer Trials — And Most Sponsors Don’t Know It’s There
Oncolytics Biotech's Type C meeting request to discuss a single-arm registrational pathway for pelareorep in anal cancer is more...
The EMA’s Virtual Control Group Gambit Could Redraw the Map for Pivotal Trial Design
The EMA has opened consultation on a draft qualification opinion for virtual control groups — a methodology that, if...
One Biomarker, Two Diseases: The p-tau Signal That Just Complicated Your Stratification Strategy
A multicenter cross-sectional study in Nature Medicine shows serum p-tau—the cornerstone of Alzheimer's blood-based diagnostics—may also detect systemic amyloidoses....